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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePD-L1 IHC 28-8 PHARMDX (MELANOMA INDICATION)
Generic NameImmunohistochemistry assay, antibody, programmed death-ligand 1
ApplicantDako North America, Inc.
6392 Via Real
Carpinteria, CA 93013
PMA NumberP150027
Supplement NumberS001
Date Received07/07/2016
Decision Date10/05/2016
APCB Date03/13/2017
Product Code PLS 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for addition of the PT Link PT200 for pre-treatment of tissue sections prior to staining with PD-L1 IHC 28-8 pharmDx.
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